FLEXI-SEAL 418000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00768455117178), received between Mar 7, 2017 and Feb 1, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "WE RECENTLY HAD A PATIENT WHERE THE FLEXISEAL WAS UTILIZED FROM 12/24/2023 -1/6/2024. UPON DISCONTINUATION OF THE RECTAL TUBE THE PATIENT WAS NOTED TO HAVE INFARCTED TISSUE EXTRUDING FROM THE RECTUM AND ALSO DEVELOPED A RECTOVAGINAL FISTULA." THE DEVICE WAS INSERTED (B)(6) 2023 IN A FEMALE PATIENT WITH LIQUID STOOL. NO DETAILS ABOUT INSERTION OR PATIENT INFORMATION AVAILABLE. THE DEVICE WAS REMOVED (B)(6) 2024 AS THEY WANTED TO GIVE IMODIUM AND REMOVE THE DEVICE. UPON REMOVAL THE BEDSIDE NURSE NOTED NECROTIC TISSUE EXTRUDING FROM THE RECTUM. THE NURSE REPORTED 45CC OF FLUID IN BALLOON UPON REMOVAL. THE PATIENT REQUIRED SURGERY TO REMOVE THE NECROTIC TISSUE. DURING SURGERY THE SURGEON DISCOVERED A RECTOVAGINAL FISTULA HOWEVER HE RECOMMENDED REPAIR OF THE FISTULA AT A LATER TIME. THE SURGEON CONFIRMED WITH THE PATIENT AFTER REMOVAL THAT SHE HAD NO PREEXISTING ISSUES WITH THE RECTUM.

  Patient problems: Necrosis; Tissue Breakdown

  MAUDE report 18621702 ↗
• InjuryDec 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A "FULL THICKNESS PRESSURE INJURY TO THE PERINEUM". IT WAS UNKNOWN HOW LONG THE FECAL MANAGEMENT SYSTEM (FMS) DEVICE HAD BEEN IN PLACE, THE PATIENT WAS A TRANSFER FROM ANOTHER FACILITY AND HAD THE FMS DEVICE IN PLACE. THE PATIENT WAS DESCRIBED AS BEING "VERY SICK AND POSSIBLY EXPIRED". MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION REGARDING THIS PATIENT AND THE DEVICE. THE TERRITORY MANAGER WILL BE GOING TO THE HOSPITAL ON (B)(6) 2020 FOR FOLLOW-UP IN-SERVICING IN THE INTENSIVE CARE UNITS. NO ADDITIONAL INFORMATION WAS RECEIVED. NO PHOTOS RECEIVED. NO LOT NUMBER AVAILABLE.

  Patient problems: Tissue Breakdown

  MAUDE report 10931653 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT IN THE HOSPITAL "MALE IN HIS SIXTIES WITH COVID-19 (CORONAVIRUS DISEASE 2019) AND VENTILATOR DEPENDENT, WAS NOTED TO HAVE A 2CM X 2CM PARTIAL TO FULL THICKNESS WOUND AT THE DISTAL ANAL SPHINCTER AFTER APPROXIMATE TWO TO THREE WEEKS OF FECAL MANAGEMENT SYSTEM (FMS) PLACEMENT". THE DEVICE WAS REMOVED AND NOT REPLACED. IT WAS FURTHER REPORTED THAT AFTER REMOVAL OF THE FMS THE COVID DIARRHEA CONTINUES. THEY ARE USING TRIAD OINTMENT TO THE PERIANAL SKIN AND IT HAS NEARLY HEALED. MULTIPLE ATTEMPTS TO COMMUNICATE WITH THE COMPLAINANT WERE MADE BUT, NO RESPONSE WAS RECEIVED FROM THE COMPLAINANT. THE DATES THE FMS WAS PLACED, AND THE DATE IT WAS REMOVED ARE NOT AVAILABLE. NO PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE RECEIVED. NO LOT NUMBER PROVIDED.

  Patient problems: Diarrhea; Tissue Breakdown

  MAUDE report 10172037 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  IT WAS REPORTED THAT "(B)(6)-YEAR-OLD PATIENT TRANSFERRED TO FACILITY ON FOR FURTHER MANAGEMENT OF BULLOUS PEMPHIGOID AND HEMATOCHEZIA. GASTROINTESTINAL (GI) CONSULT WAS FOLLOWING PATIENT. A RECTAL TUBE SYSTEM WAS INSERTED AND FIVE DAYS LATER, IN THE LATE EVENING, THE PATIENT HAD FRANK BLOOD PER RECTUM/TUBE, HYPOTENSION, TACHYCARDIA AND HEMOGLOBIN (HB) DROP TO 6.2. PATIENT RESUSCITATED WITH MASSIVE TRANSFUSION PROTOCOL (MTP) AND TRANSFERRED TO INTENSIVE CARE UNIT (ICU) WHERE RECTAL TUBE REMOVED. COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED ARTERIAL BLEED IN LOWER SIGMOIDOSCOPY REVEALED EROSION AND CLIPPED LESION X3 AND EPISCLEROSED. PATIENT EXPIRED ELEVEN DAYS AFTER DEVELOPING SEPTIC SHOCK (SKIN SOURCES AND/OR ASPIRATION PNEUMONIA). THE USER FACILITY NOTES "WE HAVE HAD SEVERAL INCIDENTS WHERE THE BALLOON WAS OVER INFLATED". MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY TO OBTAIN FURTHER DETAILS OF THE INCIDENT WITH NO RETURN CALL RECEIVED. NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT. NO PHOTOGRAPHS RECEIVED DEPICTING THE REPORTED COMPLAINT OR HARM.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Septic Shock; Tachycardia; Tissue Breakdown

  MAUDE report 10160175 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  IT WAS REPORTED THAT ¿AT NOON, THE PATIENT WAS NOTED TO HAVE SOME STOOL IN HIS RECTAL TUBE, AS WELL AS SOME LEAKING AROUND IT. THE BEDSIDE NURSES AND THE PATIENT CARE ASSISTANT (PCA) TURNED THE PATIENT, CLEANED HIM, PERFORMED WOUND CARE TO HIS BACK, AND FLUSHED THE RECTAL TUBE AS WELL AS DEFLATED IT TO REPOSITION THE TUBE. THERE WAS A TOTAL OF 95CC IN THE BALLOON KEEPING THE RECTAL TUBE IN PLACE. ON THE BALLOON PORT, IT IS NOTED THAT ONLY <45CC IS MEANT TO BE INSTILLED. THE PATIENT THEN BEGAN PROFUSELY BLEEDING FROM HIS RECTUM INTO THE BED. HEPARIN WAS IMMEDIATELY TURNED OFF (ON ORIGINALLY FOR EXTRACORPOREAL MEMBRANE OXYGENATION - ECMO) AND SAFELY BROUGHT TO IR (INTERVENTIONAL RADIOLOGY) AFTER AN MASSIVE TRANSFUSION PROTOCOL (MTP) WAS COMPLETED AND HE WAS RESUSCITATED. A TOTAL OF 6L BRIGHT RED BLOOD WAS SUCTIONED OUT OF THE BED. INTENSIVE CARE UNIT (ICU) AND COMPUTERIZED TOMOGRAPHY (CT) SURG AT BEDSIDE. THE RECTAL TUBE WAS NOT EVER REPLACED". THE USER FACILITY NOTES "WE HAVE HAD SEVERAL INCIDENTS WHERE THE BALLOON WAS OVER INFLATED". MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY TO OBTAIN FURTHER DETAILS OF THE INCIDENT WITH NO RETURN CALL RECEIVED. NO LOT NUMBER WAS PRO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10160129 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "ONE OF THEIR PATIENTS HAD DEVELOPED A FULL THICKNESS ULCERATED U-SHAPE AREA AT THE 6-O CLOCK SITE OF THE ANUS. THE DATE OF DISCOVERY WAS (B)(6) 2019 AND THE DEVICE HAD BEEN IN FOR THREE (3) WEEKS, BUT AN EXACT DATE WAS NOT KNOWN". THE INDICATION FOR THE DEVICE WAS "C-DIFF (CLOSTRIDIUM DIFFICILE) ". THE PATIENT WAS IN THE INTENSIVE CARE UNIT. THERE WAS NO TREATMENT INFORMATION PROVIDED TO WOUND AND "NO PROCEDURES WERE NECESSARY RELATED TO THE INJURY". ADDITIONAL INFORMATION WAS PROVIDED INFORMING THAT IT IS UNKNOWN IF THE PATIENTS¿ ANUS OR SURROUNDING SKIN WAS EXAMINED PRIOR TO PRODUCT INSERTION OR HOW OFTEN THE SITE OBSERVED FOR ANY SIGNS OF TISSUE DAMAGE. THE PRODUCT WAS REMOVED. THE PATIENT EXPIRED IN THE REPORTING FACILITY, UNRELATED TO THE INJURY THE OFFICIAL CAUSE OF DEATH IS "RESPIRATORY FAILURE/ WITHDRAWAL OF CARE".

  Patient problems: Tissue Breakdown

  MAUDE report 8676621 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE HAD BEEN ADMITTED TO THE INTENSIVE CARE UNIT. A FLEXI SEAL WAS PLACED (B)(6) 2019 TO PROFUSE WATERY DIARRHEA IN ORDER TO CONTAIN THE EFFLUENT AND DIVERT IT AWAY FROM A BUTTOCK WOUND. THE SAME DAY THE PATIENT EXPERIENCED TWO SEIZURES AND CARDIAC ARREST AND WAS STARTED ON VASOPRESSORS INCLUDING LEVOPHED. IT IS NOT THOUGHT THAT THE SEIZURES OR CARDIAC ARREST WERE RELATED TO USE OF THE FECAL MANAGEMENT SYSTEM (FMS). THE PATIENT WENT INTO SEPTIC SHOCK RELATED TO PRE-EXISTING URINARY TRACT INFECTION AND HAD TO HAVE HEMODIALYSIS DUE TO ACUTE RENAL FAILURE. SHE ALSO EXPERIENCED AN UPPER GASTROINTESTINAL (GI) BLEED RELATED TO AN ULCER AND A LOWER GI BLEED BUT NOT THOUGHT TO BE RELATED TO THE FMS. ON (B)(6) 2019, RECTAL BLEEDING AND THE NECROTIC PROLAPSED HEMORRHOID WAS NOTED. A SURGICAL CONSULT ADVISED TO DISCONTINUE THE USE OF THE FMS BUT, NO OTHER INTERVENTION PROVIDED. THE PATIENT CONTINUED TO HAVE WATERY, DIFFUSE DIARRHEA UNTIL HER TRANSFER TO YALE FOR A HIGHER LEVEL OF CARE. THE REPORTED INFORMED THAT THERE IS NO DOCUMENTATION OF A RECTAL EXAMINATION BEING PERFORMED PRIOR TO THE DEVICE INSERTION AND THE DEVICE WAS IN PLACE FOR ELEVEN DAYS. A PHOTOGRAPH DEPICTING THE

  Patient problems: Necrosis; Tissue Damage

  MAUDE report 8536942 ↗
• InjuryApr 18, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH A FLEXI-SEAL SIGNAL FMS DEVICE BECAUSE OF DIARRHEA. THE FMS SIGNAL DEVICE WAS INSERTED ON (B)(6) 2018. IT WAS UNKNOWN IF A RECTAL EXAM WAS PERFORMED PRIOR TO INSERTION, AS THERE WAS NO RECORD OF RECTAL EXAMINATION FOUND. THE CUSTOMER INDICATED THAT PRIOR TO INSERTING THE FMS DEVICE, THE PATIENT¿S PERIANAL-RECTAL AREA WAS RED, AND THERE WERE MANY BIG HEMORRHOIDS. IT WAS FURTHER REPORTED THE PATIENT¿S SKIN WAS VERY THIN DUE TO TREATMENT WITH STEROIDS. THE CUSTOMER REPORTED THAT THE FMS WAS REPLACED THE (B)(6) 2018 AND NO ULCERS WERE OBSERVED THAT DAY. ADDITIONALLY THE CUSTOMER REPORTED ¿45 ML WAS ENTERED IN TO THE CUFF WHEN APPLYING FMS SIGNAL. A FEW DAYS BEFORE REMOVAL OF FMS SIGNAL, 5 ML WAS WITHDRAWN FROM THE CUFF BECAUSE OF MINOR LEAKAGE. ON (B)(6) 2018, THE NURSE NOTED THE PATIENT¿S RECTUM WAS VERY ¿OPEN¿ AND NOTED AT LEAST 3 PRESSURE ULCERS IN THE AREA BETWEEN PERINEUM, SPHINCTER AND AMPULLA RECTI. THE PRESSURE ULCERS WERE REPORTED TO BE CATEGORY 2-3. IT WAS FURTHER REPORTED THAT THE NURSE INDICATED THE FMS BALLOON WAS ¿PLACED VERY LOW, MAYBE PLACED IN THE SPHINCTER AREA BUT SHE IS NOT SURE AND MAYBE IT HAS FALLEN A BIT OU

  Patient problems: Blood Loss; Pressure Sore/Ulcer; Skin Irritation; Tissue Damage

  MAUDE report 7441325 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NURSE REPORTED THAT THE PATIENT HAD A FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM (FMS) INSERTED DUE TO HAVING C-DIFFICILE AND A STAGE 4 SACRAL ULCER. IT WAS REPORTED THAT 30CC OF FLUID WAS INSTILLED INTO THE RETENTION BALLOON AT THE TIME OF INSERTION. THE NURSE INDICATED THAT A RECTAL EXAM WAS PERFORMED PRIOR TO INSERTING THE DEVICE. AFTER THE DEVICE HAD BEEN IN PLACE FOR APPROXIMATELY 2-3 WEEKS, THE NURSE NOTED AN UNSPECIFIED AMOUNT OF STOOL LEAKING AROUND THE DEVICE. AT THIS TIME, AN ADDITIONAL 6CC OF FLUID WAS ADDED INTO THE RETENTION BALLOON. THE NEXT DAY, THE PATIENT EXPERIENCED A ¿MASSIVE¿ GI BLEED AND WAS TAKEN IMMEDIATELY TO THE OPERATING ROOM FOR SURGERY. PRESSURE WAS APPLIED AND THE BLEEDING AREA WAS LIGATED. THE USE OF FMS WAS DISCONTINUED, AND THERE WAS NO FURTHER BLEEDING. A FOLLOW-UP COLONOSCOPY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE DIFFUSE DIVERTICULITIS DISEASE AND INTERNAL HEMORRHOIDS. THE WOUND OSTOMY CONTINENCE NURSE INDICATED THE SUTURES WERE SO LOW THEY COULD BE SEEN HANGING OUT OF THE RECTUM, AND THAT IT WAS POSSIBLE THAT THE FMS DEVICE HAD BEEN RUBBING ON THE HEMORRHOIDS. THE FMS DEVICE WAS DISCONTINUED AND THE PATIENT OUTCOME WAS REPORTED AS ¿NO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7430131 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NURSE REPORTED THE HOSPICE PATIENT HAD THE FLEXI-SEAL FECAL MANAGEMENT SYSTEM (FMS) INSERTED DUE TO DIARRHEA. THE NURSE INDICATED THE DEVICE WAS IN USE FOR 28 DAYS. THE NURSE STATED THE ¿FMS TUBING RUBBED AGAINST THE MUCOSA OF THE RECTUM RESULTING IN INJURY.¿ THE PRESSURE INJURY WAS REPORTED AS ¿UNSTAGEABLE¿ AND WAS TREATED WITH A PACKED DRESSING. AT AN UNSPECIFIED TIME AFTER THE REPORTED EVENT, THE PATIENT EXPIRED. THE NURSE STATED SHE ¿DIDN¿T THINK THE COD (CAUSE OF DEATH) WAS RELATED TO THE FLEXI ISSUES AT ALL.¿ ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

  Patient problems: Erosion; Pressure Sore/Ulcer

  MAUDE report 7393746 ↗
• InjuryDec 18, 2017Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE NURSE REPORTED A PATIENT EXPERIENCED BLEEDING AFTER A FLEXI-SEAL SIGNAL FMS DEVICE WAS REMOVED. THE ORIGINAL FMS INSERTION DATE AND AMOUNT OF FLUID INSTILLED IN RETENTION BALLOON WERE REPORTED AS UNKNOWN. THE REPORTER STATED ¿THE FIRST DATE, IT WAS CHARTED ON WAS (B)(6) 2017 AT 0800 AND JUST STATED IRRIGATED.¿ THE ORIGINAL FMS DEVICE WAS DISCONTINUED ON (B)(6) 2017 WITH NO REPORTED BLEEDING, AND WAS REPLACED WITH A ¿RECTAL BAG.¿ ON (B)(6) 2017, THE SICU PHYSICIAN ORDERED RE-INSERTION OF A FLEXI-SEAL DEVICE FOR 48 HOURS DUE TO SEVERE WATERY DIARRHEA. IT WAS REPORTED THAT A FLEXI-SEAL SIGNAL FMS DEVICE WAS INSERTED USING 45ML OF WATER IN THE RETENTION BALLOON. IT WAS FURTHER REPORTED THAT THE DEVICE WAS IRRIGATED ON (B)(6) 2017. AT MIDNIGHT ON (B)(6) 2017, THE FMS DEVICE WAS REMOVED. AT THIS TIME, BLOOD CLOTS WERE NOTED, AND IT WAS REPORTED THAT THERE WAS 70ML OF WATER IN THE RETENTION BALLOON. THE NURSE REPORTER INDICATED SHE SPOKE WITH A STAFF MEMBER REGARDING THE DOCUMENTATION AND THE PHYSICIAN ORDER, AND THE STAFF MEMBER SAID SHE DID NOT KNOW ABOUT THE ¿BUTTON INDICATOR¿ ON THE FMS DEVICE. LAB WORK WAS DRAWN, AND THE PATIENT UNDERWENT A FLEXIBLE SIGMOIDOSCOPY. THE PATIENT WAS

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 7126520 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NURSE REPORTED THAT AFTER REMOVING THE FLEXI-SEAL SIGNAL FMS DEVICE, THE PATIENT EXPERIENCED ¿STRONG¿ BLEEDING. HOWEVER, IT WAS NOTED, "IT IS NOT SURE THAT IT IS RELATED TO THE DEVICE." THE PATIENT WAS DESCRIBED AS A COMPLICATED CARDIAC SURGERY PATIENT AND WAS SCHEDULED FOR HEART SURGERY. THE PATIENT WAS HAVING FULLY LIQUID STOOLS, AND REQUIRED A PROLONGED STAY IN BED. AFTER A DIGITAL RECTAL EXAM WAS PERFORMED, THE FMS DEVICE WAS PLACED AND THE RETENTION BALLOON WAS FILLED WITH 45ML OF LIQUID. FIVE DAYS AFTER PLACEMENT, THE DEVICE WAS NOT REPOSITIONED AGAIN, BUT REMOVED AS THE ACUTE DIARRHEA HAD RESOLVED SPONTANEOUSLY. FIVE HOURS AFTER THE DEVICE WAS REMOVED, THE BLEEDING WAS NOTED AND THE PATIENT REQUIRED A TRANSFUSION. A RECTOSCOPY WAS PERFORMED WHICH REVEALED A TISSUE ULCERATION AND REQUIRED CAUTERIZATION WITH METAL CLIPS AND HEMOSTATIC POWDER. THE EVENT DID NOT EXTEND THE PATIENT'S ADMISSION, NOR PROLONGED HOSPITALIZATION. PHOTOGRAPHS DEPICTING THE REPORTED ISSUE WERE PROVIDED. THE PATIENT OUTCOME WAS REPORTED AS HAVING A POSITIVE POST-OPERATIVE COURSE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blood Loss; Tissue Damage; Ulceration

  MAUDE report 7104861 ↗
• InjuryOct 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NURSE REPORTED THE PATIENT DEVELOPED ANAL-RECTAL ULCERATIONS WITH BLEEDING AND CLOTS WHILE USING AN FMS DEVICE. THE DEVICE WAS INSERTED ON (B)(6) 2017. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED RECTAL BLEEDING, AT WHICH TIME ANTI-COAGULANT MEDICATIONS (HEPARIN AND BABY ASPIRIN) WERE DISCONTINUED. THE FMS DEVICE WAS REMOVED ON (B)(6), 2017. A SCOPE WAS PERFORMED BY THE GASTROINTESTINAL PHYSICIAN, AND THE PATIENT WAS TREATED WITH A CLIP IN THE RECTUM. LABS WERE DRAWN, AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED. THE PATIENT WAS DIAGNOSED WITH ¿ANAL RECTAL ULCER S/P EPI AND CLIP DUE TO RECTAL TUBE PLACEMENT.¿ NO INFORMATION WAS PROVIDED REGARDING IF A RECTAL EXAM WAS PERFORMED PRIOR TO PLACEMENT OF THE DEVICE, OR HOW MUCH FLUID WAS INSTILLED IN THE RETENTION BALLOON. THE PATIENT OUTCOME WAS REPORTED AS STABLE. NO PHOTOGRAPHS ARE AVAILABLE.

  Patient problems: Blood Loss; Pressure Sore/Ulcer

  MAUDE report 6944768 ↗
• InjuryOct 10, 2017Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  A WOUND CARE NURSE REPORTED THAT A PATIENT WHO WAS ALREADY HOSPITALIZED (REASON NOT PROVIDED) WAS TREATED WITH A FLEXI-SEAL BECAUSE OF DIARRHEA. THE PATIENT HAD STAGE 4 PRESSURE ULCERS (CLOSE TO THE BONES) ON THE LOWER BACK AFTER HAVING BEEN SITTING UP IN A CHAIR WITH A FLEXI-SEAL IN PLACE. A WOUND REVISION WAS PERFORMED (DATE NOT PROVIDED). IT WAS REPORTED THAT THE WOUNDS CAUSED BY FLEXI-SEAL EXTENDED THE LENGTH OF THE HOSPITALIZATION, BUT IT WAS UNKNOWN FOR HOW LONG. THE WOUND CARE NURSE STATED THAT ¿IT IS NOT THE FLEXI-SEAL`S FAULT BUT BECAUSE OF WRONG POSITIONING.¿ ALTHOUGH REQUESTED, NO INFORMATION WAS PROVIDED REGARDING HOW LONG THE DEVICE WAS IN USE, THE LENGTH OF TIME THE PATIENT WAS POSITIONED SITTING UP IN A CHAIR, OR PATIENT OUTCOME.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 6939129 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT RECEIVED FROM A NURSE REPORTING THAT ON (B)(6) 2017, "AN FMS WAS INSERTED IN A PATIENT WHO HAD AN EXISTING PERIANAL ULCER." THE SPECIFIC DETAILS ABOUT THE PERIANAL ULCER PRIOR TO FMS USE NOT PROVIDED. ON (B)(6) 2017, IT WAS IDENTIFIED THAT THE FMS PLACED IN A PATIENT WAS REMOVED AND DISCONTINUED. IT IS NOT KNOWN HOW MUCH FLUID WAS IN THE BALLOON. THE NURSE STATED THE "FMS IN PLACE WORSENED THE EXISTING PERIANAL ULCER" WHICH "HAS NOW EXTEND INTO RECTAL VAULT." SPECIFIC DETAILS ABOUT THE RECTAL ULCER AFTER FMS USE WAS NOT PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Injury; Pressure Sore/Ulcer

  MAUDE report 6395110 ↗
• InjuryMar 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT RECEIVED FROM A NURSE PRACTITIONER REPORTING THAT ON AN UNKNOWN DATE, A PATIENT "WAS INJURED AND REQUIRED SURGICAL INTERVENTION" AFTER USE OF THE DEVICE. NO FURTHER DETAILS WERE AVAILABLE. MULTIPLE ATTEMPTS AT FOLLOW UP WERE UNSUCCESSFUL.

  Patient problems: Injury; Tissue Damage

  MAUDE report 6385123 ↗